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Study of the Management of Vaginal Discharge in West African Using Single Dose Treatments

This study has been completed.
Canadian International Development Agency
Information provided by:
Université de Sherbrooke Identifier:
First received: April 7, 2006
Last updated: NA
Last verified: September 2005
History: No changes posted

This randomised controlled trial aimed to verify whether directly observed single dose treatment (with tinidazole+fluconazole) would be as effective as the longer standard treatments (metronidazole for 7 days, plus vaginal clotrimazole for 3 days) in the syndromic management of women presenting with vaginal discharge in primary health care centers of Ghana, Togo, Guinea and Mali. It was designed as an effectiveness trial, i.e. it was done under conditions typical of routine work in these health centers

Condition Intervention Phase
Bacterial Vaginosis
Drug: tinidazole+fluconazole vs metronidazole+clotrimazole
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomised Controlled Trial of Single Dose Tinidazole+Fluconazole Versus Longer Courses of Metronidazole+Clotrimazole in the Management of West African Women With Vaginal Discharge

Resource links provided by NLM:

Further study details as provided by Université de Sherbrooke:

Primary Outcome Measures:
  • Symptomatic resolution of the vaginal discharge according to the patient

Secondary Outcome Measures:
  • Objective resolution of the vaginal discharge according to the study nurse or medical officer

Estimated Enrollment: 1524
Study Start Date: January 2004
Estimated Study Completion Date: May 2005
Detailed Description:

Abstract Objective: Evaluate whether single-dose treatments are as effective as standard therapy in the syndromic management of vaginal discharge.

Methods: A randomized controlled effectiveness trial comparing single-dose tinidazole plus fluconazole (TF) to seven days of metronidazole plus three days of vaginal clotrimazole (MC) among 1570 women presenting with vaginal discharge in primary health care institutions of Ghana, Togo, Guinea and Mali. Participants were randomly allocated to one of the two treatments by research nurses or physicians using pre-coded envelopes. Effectiveness was assessed by symptomatic response on day 14.

Findings: The two treatment regimens had similar effectiveness: complete resolution was seen in 66% (TF) and 64% (MC) and partial resolution in 33% (TF) and 34% (MC) of participants (p=0.26). Effectiveness was similar among subgroups with vulvovaginal candidiasis, T. vaginalis vaginitis or bacterial vaginosis. The two treatment regimens had a similar effectiveness among HIV-infected (TF: n=76, 71% complete resolution, 28% partial; MC: n=83, 72% complete, 25% partial, p=0.76) and HIV-uninfected women (TF: n=517, 68% complete, 32% partial; MC: n=466, 65% complete, 33% partial, p=0.20). Cervical infections with N. gonorrhoeae, C. trachomatis and M. genitalium were uncommon among women not involved in sex work, were associated with bacterial vaginosis or T. vaginalis vaginitis, and did not alter response to treatment with agents active against vaginal infections. Four fifths of women not relieved by single-dose TF had a favourable response when MC was administered as second-line treatment.

Conclusion: Single-dose TF is as effective as multiple-dose MC in the syndromic management of vaginal discharge, even among the HIV-infected. Given its low price and easier compliance, tinidazole/fluconazole should be considered as a first-line treatment of the vaginal discharge syndrome.


Ages Eligible for Study:   11 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • women consulting for vaginal discharge
  • local resident
  • willingness and ability to consent

Exclusion Criteria:

  • sex worker consulting for active screening
  • main complaint of lower abdominal pain
  • allergy to one of the study drugs
  Contacts and Locations
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Please refer to this study by its identifier: NCT00313131

Adabraka Polyclinic
Accra, Ghana
Suntreso Polyclinc
Kumasi, Ghana
Centre de Santé Carrière
Conakry, Guinea
Centre de Santé Madina
Conakry, Guinea
Centre de Santé d'Adakpamé
Adakpame, Togo
Clinique IST d'Agoe Nyivé
Lomé, Togo
Clinique IST d'Amoutivé
Lomé, Togo
Sponsors and Collaborators
Université de Sherbrooke
Canadian International Development Agency
Principal Investigator: Jacques Pepin, MD U of Sherbrooke
  More Information

No publications provided by Université de Sherbrooke

Additional publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00313131     History of Changes
Other Study ID Numbers: CHUS 03-32
Study First Received: April 7, 2006
Last Updated: April 7, 2006
Health Authority: Canada: Health Canada

Keywords provided by Université de Sherbrooke:
bacterial vaginosis
vaginal candidiasis

Additional relevant MeSH terms:
Vaginal Discharge
Vaginosis, Bacterial
Bacterial Infections
Genital Diseases, Female
Vaginal Diseases
14-alpha Demethylase Inhibitors
Alkylating Agents
Anti-Infective Agents
Antifungal Agents
Antiparasitic Agents
Antiprotozoal Agents
Antitrichomonal Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Radiation-Sensitizing Agents
Therapeutic Uses processed this record on November 25, 2014